Issue 5 - Feb 3, 2017
  • Soon-Shiong drops “MoonShot” trademark, but MD Anderson suit remains unresolved

    Overnight, cancer pharmaceuticals billionaire Patrick Soon-Shiong stopped using the trademark “MoonShot” to describe his health initiatives, opting instead to use the less grabby, but equally ambitious, name “cancer breakthroughs.”

  • Soon-Shiong’s journey from “Rocket Ship” to “MoonShot”—with lots of confusion

    The MD Anderson complaint against Patrick Soon-Shiong and his business entities, filed Nov. 30, 2016, in the U.S. District Court for the Southern District of Texas, argues that the controversial billionaire’s use of the moonshot trademark created confusion that affected both MD Anderson and the White House initiative headed by then Vice President Joe Biden.

  • Cancer groups: Trump travel ban could “retard scientific progress and adversely affect public health”

    President Donald Trump’s recent executive order that temporarily bars travel from seven Muslim-majority countries to the United States will negatively affect research institutions, public health, and innovation, cancer organizations say.

  • Obituary

    LeMaistre, a pioneer of cancer prevention and former MD Anderson president, dies at 92

     

    Charles Aubrey “Mickey” LeMaistre, a former president of MD Anderson Cancer and a pioneer of cancer prevention, died Jan. 27. He was 92.

  • In Brief

    • Keith Flaherty named editor-in-chief of AACR journal Clinical Cancer Research
    • Gottschalk named chair of bone marrow transplantation, cellular therapy at St. Jude
    • Guttridge named associate director for basic research at Ohio State
    • Heath named associate director for translational sciences at Karmanos
    • Howell joins Fox Chase Department of Radiation Oncology
    • NCCN establishes second policy and advocacy fellowship
  • Drugs & Targets

    • MD Anderson, Guardant form partnership to make liquid biopsy standard of care
    • Indivumed to provide tissue samples to Regeneron
    • Addario institute and Scancell form partnership focused on vaccine
    • Perthera enters collaboration with Novartis to identify patients for clinical trials
    • Benitec, Nant Capital initiate head and neck cancer programs
    • GenomeDx joins Astellas in genomic profiling collaboration
  • Funding Opportunities

    SU2C to fund Dream Teams focused on “cancer interception” in pancreas and lungs

    Stand Up To Cancer broke new ground today when the American Association for Cancer Research, its scientific partner, announced to the cancer research community funding to support new Dream Teams focused on “cancer interception” of the pancreas and lungs.

Issue 4 - Jan 27, 2017
  • How a “cool” trial in rare cancers was born

    About a year ago, Sandip Patel, a young doctor who had just joined the faculty at University of California San Diego Moores Cancer Center, stopped by to see his mentor, Razelle Kurzrock, chair of the SWOG Early Therapeutics and Rare Cancers Committee.

  • MD Anderson posts $169 million loss for first four months of fiscal 2017

    MD Anderson Cancer Center lost $58 million during the month of December 2016.

    This latest operating loss brings total losses $169.4 million for the first four months of fiscal 2017, which began on Sept. 1, 2016.

  • In Brief

    • Miami Cancer Institute Opens, joins MSKCC Alliance
    • LUNGevity, CancerCare launch helpline
    • White paper shows challenges, progress in immunotherapy
    • Study finds undisclosed conflicts in Twitter posts by oncologists
  • Drugs & Targets

    • FDA approves first drug for marginal zone lymphoma
    • Merck, Domain Therapeutics collaborate in immune-oncology
Issue 3 - Jan 20, 2017
  • “Will I still have coverage?” patients ask oncologists as Republicans move to gut Affordable Care Act

    As Congress lays down the groundwork for dismantling the Affordable Care Act, doctors across America are hearing cancer patients speak of their fear of losing access to care if the law known as “Obamacare” is jettisoned without replacement.

  • FDA forms Oncology Center of Excellence, names Richard Pazdur director

    On his last full day as FDA commissioner, Robert Califf announced the formation of the Oncology Center of Excellence and named Richard Pazdur its director.

    The process of forming the center began in June, and Pazdur has been the acting director. Reorganization of the FDA oncology portfolio is an element of the Obama White House Moonshot Initiative.

  • Guest Editorial

    NCI formulary, moonshot and public-private partnerships

    Announcing the NCI Formulary, the Jan. 13 issue of The Cancer Letter includes comments suggesting the road to new therapies will now get “easier” and other comments indicated that industry and/or NCI collaborators will “not provide support other than drug access”.

  • In Brief

    • Richard Goldberg new director of West Virginia University Cancer Institute
    • Justin Klamerus named president of Karmanos Cancer Hospital
    • Werner-Wasik new executive vice chair, radiation oncology integration at Jefferson
    • Northwell Health partners with Indivumed to create cancer research biobank
    • Tempus and University Hospitals/Seidman announce effort to customize treatment
    • Reporting of lung cancer surgery outcomes provides info about quality of care
  • Drugs & Targets

    • Medicinal product designation for TB-403 for medulloblastoma
  • Funding Opportunities

    LUNGevity issues RFA for career development award

    LUNGevity announced a request for applications for translational research for career development awards that will be granted in 2017.

Issue 2 - Jan 13, 2017
  • NCI develops a “formulary” to make it easier for cancer centers to test drug combinations

    With a simplified tech transfer agreement, six industry partners and 15 compounds (but no dedicated research funds), NCI challenges investigators to think creatively.

  • Conversation with The Cancer Letter

    Simon: The moonshot will continue, but the electronic health record industry must step up

    The National Cancer Moonshot Initiative was created by a memorandum issued by President Barack Obama.

    The wide-ranging public health initiative will cease to exist on Jan. 20—eight days short of a year after it was created—when the keys to the White House are handed over to Donald Trump.

  • In Brief

    • Sakaguchi, Ramsdell, Rudensky win Crafoord Prize for discoveries in immune regulation
    • Gustavo Leone named director of  MUSC Hollings Cancer Center
    • Levine Cancer Institute is first to earn top designation for patient-centered care
    • Martin Edelman joins Fox Chase as hematology/oncology chair
    • Diane Simeone to lead pancreatic cancer center at NYU Langone
    • Mario Contreraz named administrator of IU cancer center clinical trials office
    • Columbia, NewYork-Presbyterian and Life Raft form GIST research partnership
    • NCCN publishes patient education resources for gliomas
    • NIHCM Foundation awards $345K in investigator-initiated research grants
    • LUNGevity Foundation introduces mobile app to help patients manage lung cancer
    • NPR station broadcasts anniversary program on moonshot
    • Goldberg novel is finalist in Jewish Book award
  • Drugs & Targets

    • Merck joins ORIEN
    • Scripps to collaborate with Pfizer to advance DNA-encoded library technology
    • AbbVie announces four new global research collaborations
    • Lilly and Merck expand immuno-oncology collaboration
    • Amgen and Immatics collaborate to develop cancer immunotherapies
    • Philips and Illumina to co-develop integrated genomics solutions for oncology
    • Tecentriq receives priority review for treatment of urothelial carcinoma
    • EMD Serono and MD Anderson enter three-year collaboration
    • MD Anderson and Deerfield Management create company to inhibit autophagy
    • Cologuard earns positive review from Blue Cross Blue Shield Association
    • FDA accepts BLA for Mylan and Biocon’s biosimilar Trastuzumab
    • FDA releases guidance on nonproprietary naming of biologics
Issue 1 - Jan 6, 2017
  • Doug Lowy on the moonshot, NCI’s invigorated agenda

    As administrations change, cancer research stands in an unusually strong position, NCI Acting Director Douglas Lowy said in an interview with The Cancer Letter.

    “We’re very fortunate that both Republicans and Democrats strongly support biomedical research in general, and cancer research in particular,” Lowy said in a wide-ranging interview. “The leadership of the House and Senate appropriations subcommittees was responsible for the increase in FY16 for the NIH appropriation.”

  • MD Anderson lays off 900 staff members

    The year got off to a bad start for some employees of MD Anderson
    Cancer Center.

    As part of a cost-cutting measure announced Jan. 5, about 900 of them received layoff notices.

    Television crews crowded the parking garages of the Houston hospital, capturing images of teary-eyed people carrying boxes to their cars.

  • Biden plans to create moonshot nonprofit, may focus on drug prices

    After leaving the White House, Vice President Joe Biden plans to consolidate his work on the Cancer Moonshot into an independent, nonprofit organization, while juggling non-cancer programs at two universities.

    Biden aims to continue work on the National Cancer Moonshot Initiative through a new nonprofit that will not be connected to any cancer center or university, according to sources familiar with Biden’s post-administration goals.

  • Introducing a redesign of  The Cancer Letter

    Dear Reader,

    The Cancer Letter is starting 2017 with something we haven’t done in …
    well, ever.

  • In Brief

    • Chi Van Dang named scientific director of Ludwig Institute
    • Vacirca elected COA president
    • Ruckdeschel heads cancer institute at University of Mississippi Medical Center
    • Cassels retires as chief administrator at Winship
    • ACS names three new members to board
    • Kratzke, O’Regan chosen to leadership roles at Big Ten consortium
    • PCORI approves $42 million in funding for comparative studies on healthcare approaches
  • Drugs & Targets

    • AACR project GENIE releases cancer genomic data set
    • Strata Trial study launched with UNC, Alabama cancer centers
    • Foundation Medicine receives FDA approval as companion diagnostic
    • Ionis gets $28 million from AstraZeneca for new cancer drug
    • MaxCyte, Washington University in St. Louis announce collaboration
    • MD Anderson, Affimed collaborate on immunotherapy combination
    • Gradalis, Mount Sinai announce research alliance
    • Phylogica, Genentech extend agreement
    • Senhwa gets FDA orphan drug designation
    • Oncotype DX included in AJCC staging criteria
  • Funding Opportunities

    Addario foundation, IASLC announce grant

    The Bonnie J. Addario Lung Cancer Foundation and the International Association for the Study of Lung Cancer announced the second annual joint fellowship award to support research on the early detection of lung cancer.

Issue 46 - Dec 16, 2016
  • FDA Finds Lapses in Reporting of Patient Harm, Deaths Resulting from Medical Devices in Hospitals Nationwide

    After a broad survey of reporting standards at hospitals across the U.S., an FDA investigation recently concluded that the vast majority of the 17 institutions inspected did not file timely reports of injuries and deaths caused by medical devices.

    The inspections earlier this year were triggered by public scrutiny of power morcellation, a surgical procedure known to spread undetected uterine cancer via the device’s spinning blades, as well as by reports of infections associated with contaminated duodenoscopes, flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine.

  • Conversation with The Cancer Letter

    FDA: For Hospitals that Significantly Violated Federal Adverse Event Reporting Requirement, No Additional Action Necessary

    In a 17-institution inspection sparked by reports of patient harm and death resulting from power morcellators and contaminated duodenoscopes, FDA found that nearly all hospitals surveyed either failed to report adverse events or didn’t have proper reporting and documentation procedures in place.

  • Hackensack Cancer Center, MSKCC Form Business, Clinical Partnership in New Jersey

    Memorial Sloan Kettering Cancer Center and Hackensack Meridian Health announced a 10-year partnership deal that, in its initial stages, will involve developing joint standards of care that will be applied across their operations.

  • Obama Signs Cures Act, Funding Biden’s Moonshot and Boosting NIH, NCI, FDA Budgets Over 10 Years

    President Barack Obama Dec. 13 signed the 21st Century Cures Act, a bill that changes regulatory standards at FDA, slates additional research funds for NIH, and authorizes $1.8 million over seven years for Vice President Joe Biden’s National Cancer Moonshot Initiative.

  • Editorial

    The Year of the Moonshot

    The moonshot, The Cancer Letter’s biggest area of coverage of 2016, continues into 2017.

    With the passage of the 21st Century Cures Act, the cancer moonshot initiative has been authorized at $1.8 billion over seven years. The Cures Act also authorizes $500 million over the next decade for FDA to streamline drug and device approval processes (The Cancer Letter, Dec. 10).

  • In Brief

    • Bertagnolli elected ASCO president
    • CMS abandons Medicare Part B payment experiment
    • Maki joins leadership of Northwell Health and Cold Spring Harbor
    • Neufeld named clinical director, physician-in-chief & EVP at St. Jude
    • Anderson appointed CEO of Genentech
    • Brown gives $30 million to IU immunotherapy center
    • Mulva family donates $75 million to UT Austin, MD Anderson
    • Collins receives FASEB Public Service Award
    • Proton Partners to build new cancer center at Thames Valley Science Park, UK
    • ACCC launches online resource for metastatic breast cancer
  • Drugs & Targets

    • Keytruda becomes first anti-PD-1 therapy to receive a CHMP positive opinion for previously untreated NSCLC
    • Nintedanib receives orphan drug designation for mesothelioma
    • ABTL0812 receives orphan drug designation for Pancreatic Cancer
Issue 45 - Dec 9, 2016
  • DePinho Accepts Responsibility As MD Anderson’s Losses Grow

    Operating losses at MD Anderson Cancer Center ballooned again in October—swelling to $60.9 million on top of September’s $41.5 million.

    Losses for the first two months of fiscal year 2017 add up to $102.4 million, and the institution’s executives are scrambling to cut costs, boost revenues, and shore up faculty morale.

  • Senate Approves 21st Century Cures; CR Slates $300M for NCI and Moonshot

    The Senate approved the 21st Century Cures Act, a wide-ranging bill that authorizes $1.8 billion over seven years for cancer research as well as $500 million over the next decade for FDA to streamline drug and device approval processes.

  • Being an Acting Director, NCI’s Lowy Isn’t Required to Submit Resignation

    Doug Lowy will continue to lead NCI in his role as acting director in 2017 unless president-elect Donald Trump decides to appoint a different, new director.

  • In Brief

    • Drebin appointed chair of surgery at MSKCC
    • Brown named director of Inova Center for Drug Discovery and Development and Targeted Therapeutics
    • Vogelstein to receive the KNAW Bob Pinedo Cancer Care Award
    • Surgeon General issues report on electronic cigarettes
    • Zinner elected chair of American College of Surgeons board of regents
    • Jenkins retires from FDA Office of New Drugs
    • Tempus, Abramson Cancer Center collaborate on immunotherapy
    • Parker Institute, CRI form collaboration on neoantigens
    • AbbVie, Northwestern and Hopkins announce collaborations
    • GW launches the GW Cancer Center
    • St. Jude marathon raises $10 million
    • Coleman named VP of medical affairs at GenomOncology
    • Hesse named president, CEO of CTCA Philadelphia center
    • Hillman, Patti, Weinreb receive ACR Gold Medal
    • UT Health Northeast in Tyler, TX, joins MD Anderson Network
  • Drugs and Targets

    • Avastin plus chemo gets FDA approval for a type of ovarian cancer
    • EC Grants Conditional Approval for AbbVie’s Venclyxto for CLL
    • Amgen and Allergan seek EMA approval of biosimilar bevacizumab
    • Whole genome sequencing center established in Singapore
Issue 44 - Dec 2, 2016
  • House Passes 21st Century Cures Act, Slating $4.8 Billion for NIH, Moonshot

    The House of Representatives has approved a revised version of the 21st Century Cures Act, a comprehensive $6.3 billion health care reform measure that would fund the National Cancer Moonshot Initiative and amend FDA standards for regulating drugs and devices.

  • Just as Feared: House Version of Cures Bill Gives Moonshot Money to NIH Director

    In an unusual move, the National Cancer Advisory Board fired off a letter urging Congress to authorize additional “moonshot” funds, and—just as importantly—to place these new funds in the NCI budget.

    The NCAB letter, dated Nov. 22, was likely motivated by insider accounts of a drive by top NIH officials to intercept these new dollars and place them under the purview of the NIH director (The Cancer Letter, Nov. 4).

  • Letter To The Editor

    Pressures Notwithstanding, MD Anderson Projects Positive Margin in Fiscal 2017

    Dear Editor,

    It was with disappointment that I read the Nov. 4 issue of The Cancer Letter. I feel it is my duty to respond to address inaccuracies that are not only potentially damaging to The University of Texas MD Anderson Cancer Center, but might unnecessarily scare patients who are coming to our institution for cancer care and hope.

  • In Brief

    • Tuveson named director of Cold Spring Harbor
    • City of Hope and Translational Genomics Research Institute to collaborate on precision medicine
    • $50 million to fund prostate cancer research among veterans
    • MSKCC to offer surgery outside Manhattan
    • NCCN guidelines & app help patients combat nausea and vomiting
    • NCCN imaging appropriate use criteria published for 15 guidelines
    • Guardant360 the preferred liquid biopsy test at Northwestern University
    • Dietrick named chief value officer at Chesapeake Urology
    • City of Hope’s Salgia receives 2016 Asclepius Award
    • Southern Research awarded NCI contract
  • Drugs & Targets

    • Darzalex receives FDA approval for multiple myleoma
    • Iclusig receives full FDA approval for CML
    • Athenex and Lilly enter clinical collaboration
    • BMS, Enterome collaborate on microbiome-derived biomarkers
    • First computer-aided detection system gets FDA approval
    • Avelumab accepted for priority review by FDA
Issue 43 - Nov 18, 2016
  • Republicans Ditch 2017 Appropriations To Tailor Spending to Trump Priorities

    The House and Senate leadership postponed appropriations for fiscal 2017 in favor of a second continuing resolution that runs through March 31, 2017.

    The move Nov. 17 is likely a signal that Congressional Republicans are hoping to start the budget process anew, tailoring it to the priorities of the administration of president-elect Donald Trump.

  • MD Anderson Sues Billionaire Over Using the Word “Moonshot”

    Earlier this year, billionaire Patrick Soon-Shiong created considerable confusion by launching a cancer “moonshot” program at the same time that President Barack Obama announced an initiative that went by pretty much the same name.

    On Jan. 11, a day before Obama announced his program during the State of the Union Address, Soon-Shiong, in a draft press release, claimed that the White House, NIH, FDA and pharmaceutical companies have united to launch the “Cancer MoonShot 2020,” an immunotherapy clinical trials program that Soon-Shiong had designed.

  • In Brief

    • Libutti Named Director at Rutgers Cancer Institute
    • Beau Biden endowed chair established at MD Anderson
    • Feinstein Institute researcher introduces app to help patients with treatment options
    • Cedars-Sinai adds radiation oncology with treatment center
    • Guideline on HER2 Testing for Patients with Gastric Cancer
    • University of Pennsylvania implements tobacco-free campus policy
    • President’s Cancer Panel publishes report on connected health
    • Maintenance of certification points offered through QOPI
  • Drugs & Targets

    • Amgen, Allergan submit application for biosimilar bevacizumab
    • Midostaurin receives FDA priority review
    • Napabucasin granted Orphan Drug Designation
Issue 42 - Nov 11, 2016
  • Conversation with The Cancer Letter

    FDA Eager to Approve PD-1 and PD-L1 Drugs in Novel Combinations, New Settings

    In an in-depth interview with The Cancer Letter, an FDA official clarified the agency’s criteria for approval of drugs that target PD-1 and PD-L1.

    Last month, The Cancer Letter reported that there are 803 registered clinical trials testing 20 PD-1 and PD-L1 drugs. These trials have slots for 166,736 patients. (The Cancer Letter, Oct. 7).

    The scope of this development effort appears to be unprecedented.

  • What the Trump Presidency Means for Cancer Care, the ACA, and the Moonshot

    President Barack Obama’s legacy health care programs—the Affordable Care Act, and the National Cancer Moonshot Initiative—have been thrown into uncertainty.

    Hours after Republican Donald Trump became president-elect of the United States, Washington is left in a muddle: hopeful Democratic appointees who expected to join Hillary Clinton’s ranks ended up empty-handed. At stake is leadership at federal agencies, including the HHS, NIH, NCI, and FDA.

  • Fred Hutchinson Opens Cellular Immunotherapy Clinic

    Fred Hutchinson Cancer Research Center has opened a first-of-its-kind clinic focused on cellular-based immunotherapies for cancer patients in clinical trials.

    The Bezos Family Immunotherapy Clinic will allow researchers to conduct twice as many immunotherapy trials in the next year in pursuit of speeding cures for cancer, officials said.

  • In Brief

    • Peter O’Dwyer elected group co-chair elect of the ECOG-ACRIN
    • Charles Drake joins NY-Presbyterian/Columbia as director of genitourinary oncology. associate director at the Columbia Cancer Center, co-director immunotherapy program.
    • William Cance joins University of Arizona Cancer Center as deputy director
    • Craig Reynolds to retire as as director of the NCI Office of Scientific Operations at Frederick
    • Elisabeth Heath, of Karmanos, receives the Michigan Cancer Consortium’s inaugural Champion Award
    • Felipe Suero joins Department of Anesthesiology at Fox Chase
    • Valierie Armstead joins Fox Chase Cancer Center as professor in anesthesiology
    • Susan Rawl, of Indiana University School of Nursing and IU Cancer Center, receives $2.6M from PCORI for colorectal cancer screening research
    • IU School of Nursing establishes Champion Center for Cancer Control Research, named after Distinguished Professor Victoria Champion.
    • NCCN launches Just Bag It campaign for safe handling of vincristine 
    • Weill Cornell Medicine and New York Genome Center receive a NCI grant worth $490,000-a-year five-year grant for joint cancer genomics data center
    • John Wayne Cancer Institute and Singapore’s Clearbridge BioMedics to establish a circulating tumor cell center
    • St. Baldrick’s Foundation provides infrastructure grants to nearly 40 childhood cancer institutions
  • Drugs and Targets

    • Opdivo receives FDA approval for recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy
    • Amgen and Janssen Biotech to evaluate combination of Amgen’s Kyprolis and Janssen’s Darzalex in multiple clinical studies in multiple myeloma
    • Hopkins and BMS announce five-year collaboration to study resistance to checkpoint blockers and develop combination immunotherapies.
    • Mylan and Biocon submit BLA for biosimilar trastuzumab
    • FDA has accepts Genentech’s BLA for a subcutaneous formulation of rituximab in blood cancer indications
    • LEE011, Novartis’s selective cyclin dependent kinase inhibitor, granted FDA Priority Review
    • Verastem licenses exclusive worldwide rights to develop and commercialize Infinity’s oncology product candidate duvelisib.
    • VENTANA ALK (D5F3) CDx gets FDA approval to use on the VENTANA BenchMark ULTRA automated slide stainer
  • Funding Opportunities

    • SU2C and Genentech form “Catalyst” to provide research funding and access to compounds in effort to find new indications
    • SU2C makes $7.5 million in grants available to early-career scientists focusing on immuno-oncology
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